AI Solutions For Pharma (From Regulatory Affairs to Custom Software)

As the technology is reaching its heights, new innovations like AI can serve the pharmaceutical industry. Other side, pharma industry is under pressure from all sides—tight regulations, rising costs, and the constant need for reliable data. AI is proving to be a handy tool in both areas: it can smooth the regulatory submission process and also power the kind of software companies need to track recalls, manage risks, or just see their data in one place.

In this article, we’ll look at how AI supports both regulatory affairs and practical software solutions for pharma industry that make daily tasks easier.

Role of AI in Pharma Regulatory Submissions

Regulatory submission is a complex and crucial process. Regulatory authorities like the FDA and EMA have a strong regulatory approval pathway and it gets stronger as the risk of the product goes up. Every regulatory body is adamant about and looks forward to improve the safety of the product which is regulated by them. To minimize the rejections and maximise the market entry of the product, it is important to know what, how and when to submit the required documents.

With the use of AI in pharma, now tasks are getting simplified and can be carried out with more ease and precision. It plays a role in streamlining the pharmaceuticals regulatory process, expedited market access, a great shift in the time consuming processes like hyperlinking the documents, training the team on the SOPs… and decreased probability of errors. By implementing artificial intelligence in the pharmaceutical regulatory sector, it provides us with a lot of benefits. Let’s take a look at them.

AI Consulting Solutions For Pharma RA Services

One of the major benefits when AI is used in regulatory affairs is the time needed for the approval process. Take a look at the difference in the timeline before and after the use of AI by regulatory authorities in the down below. As per the article published in the International Journal of Biology, Pharmacy and Allied Sciences (IJBPAS) the timeline is as follows:

Apart from this some other benefits include the following:

• Faster submissions and faster approvals
• Less human effort and tracking
• Low chances for error
• Improved accuracy and efficiency
• Data analysis
• Discover new patterns and safety signals among datasets (In pharmacovigilance)
• Increased rate of regulatory compliance
• Post market surveillance including possible early risk detection.
• 24/7 access of AI driven applications
• Streamlined regulatory operations and less exhaustive

Regulatory Automation in Pharma

There are certain tools that are developed for performing tasks automatically in this field. Complex and hectic tasks can be made easy with these automation tools which enables us to use more manual power on the areas that need focus and attention. Some regulatory submission automation tools used in the pharmaceutical regulatory side are as follows:

1. Electronic Document Management System (EDMS)

VeevaVault is an example of an Electronic Document Management System. It is a leading cloud based platform used according to the needs of the life science industry. Its features include document versioning, electronic signatures, controlled access, automated workflow etc… All of these allow for efficient regulatory compliance and document management. When compared to generic document management systems, Veeva Vault is designed to serve the strict regulatory requirements.

2. Regulatory Information Management (RIM) System

To keep a track of the regulatory documents and activities throughout the product development and its lifecycle. To verify that the product satisfies all the required regulatory standards for market approval as well as post marketing surveillance the regulatory affairs team utilize the RIM system. They also utilize the RIM system to keep the product information up to date. An example is Aris Global’s Regulatory One platform. Can be used for regulatory submissions, product registrations, commitments, tracking and regulatory intelligence management.

3. AI (Artificial Intelligence) Analytical Tools like the Informatica Axon Data Governance analyze and govern the dataset including the regulatory information using the AI and machine learning algorithms. It helps with the identification of issues regarding the quality of the data, compliance with regulations like the GDPR (General Data Protection Regulation) and HIPAA (Health insurance Portability and Accountability Act). Also via automated data profiling, data lineage, tracking and anomaly detection, the data governance can be improved.

4. Natural Language Processing (NLP) tools can be used to evaluate the market potential of a novel drug compound or medicine. The NLP algorithm allows for the extraction of key features from data that are not structured. This leads to expedited review procedure and prevents from missing any crucial information. Apart from this, AI driven NLP can be applied for analysing complex and elaborate regulatory documents like the medicine, safety reports, labelling and scientific literature more efficiently. An example is Linguamatics I2E.

5. Submission Publishing Tools efficiently generate a range of submission output formats like CTD for paper publications, eCTD and NeeS (non eCTD electronic submission) for electronic publication, VNeeS for the veterinary section and e copy for the medical devices. Example of such a tool is the Lorenz Docubridge

Link Between Pharmaceutical Companies, AI & Regulatory Compliance

The pharmaceutical companies develop a medicine or any product and then seek approval from the respective regulatory authority of the country/ countries in which they wish to market. Even though the regulatory authority of different countries has the same aim (consumer safety and effectiveness), there will always be variations in their procedure and the documents to be submitted.

In addition to this, the regulatory requirements will be changing from time to time. New rules may come into effect, old rules may not exist anymore or say some rules apply partially or only to certain products etc. So it is always important to stay updated at all times even though you have already worked with the same regulatory body. This is where AI can help us intensely. We cannot always keep track of every single detail that has been made.

The companies can search for

• The regulatory process flow of a product approval in various region
• Documents that are mandatory
• Any omissions of documents can be made or
• Can the product skip any step in its approval journey
• Any region specific procedures or certificates to be required
• Special rules or region specific rules, fee structure, form etc..

In all these areas AI provides guidance to anyone who wishes to market their product in the market and thereby improving operational efficiency.

AI-Powered Pharma Software Solutions

Running a pharma business comes with a long list of moving pieces. One week it’s a recall notice, the next it’s a sudden change in regulations, and in between there’s a constant flow of supplier data to make sense of. Trying to track all that with spreadsheets alone is frustrating and, honestly, risky. That’s why more companies are leaning on pharma regulatory software and other digital tools to take the pressure off.

This is where we usually step in. Depending on the need, that might mean building a dashboard, putting a risk tool in place, or creating customised AI for pharmaceuticals to tie everything together. Whatever the format, the purpose is simple: help teams see the important stuff clearly and act on it faster.

Why To Hire Pharma AI Consultant?

A pharma AI consultant makes use of artificial intelligence and machine learning to help pharmaceutical companies solve complex problems. These can be problems arising at any phase of the product journey, that is, from drug development to regulatory compliance, marketing and custom AI software solutions. Example for areas it serves as an advantage are:

• Drug Development: Aids in target identification, lead optimisation. AI also predicts the results of the clinical trials of the product in question.
• Treatment Personalization: AI can analyse patient data like the medical history and can identify patterns that lead to disease prediction. Customise the treatment according to the patient’s medical and genomic data thereby making it more effective.
• Clinical Trials: Can save time and resources instead of using it for clinical trials that have lesser market demand. AI aids in selecting the right candidate for clinical trials as per the inclusion and exclusion criteria. Point out any anomalies within the trial data.
• Marketing and Regulatory Compliance: AI allows us to utilize it for marketing strategy, to know the region wise market value, can predict the demand of the product and more. AI can analyse large datasets and helps us to make sure it complies with the regulatory requirements.
• Data & Software Tools: AI isn’t just useful for research or compliance—it can also sit at the heart of everyday tools. Think dashboards that bring scattered pharma data into one screen, tracking systems that flag issues early, or analytics that help teams see trends they’d otherwise miss. In practice, these tools save time and give managers a clearer picture of what’s going on.

How To Choose The Right AI Tool For Pharma Industry?

To run the regulatory operation smoothly it is crucial to select the right AI tools. There are some points to be considered while picking an AI tool to perform the regulatory functions.

• Select tools that are validated. This is to make the decisions and predictions accurate and more reliable.
• Can it be used for submission, planning, labelling and other activities concerning regulatory affairs.
• Are the decisions made or the work done by the tool satisfiable? Is it reliable?
• Is it stable or can it handle large datasets?

Confused on choosing the apt AI tools for your product journey? Artixio provides AI Consulting Services For Healthcare Industries for faster market access. By leveraging Artixio’s AI driven compliance services, turn your dream into existence.

Conclusion

Artificial Intelligence when integrated with the pharmaceutical regulatory sector presents us with endless advantages. Regulatory rules and requirements are made such that it never allows a sacrifice in safety and effectiveness of the product. Rules and requirements will become more stringent and will be expected to comply with.

Leveraging AI and AI tools always help us stay updated in this rapidly evolving regulatory framework. It has already become a part of the pharmaceutical regulatory affairs, from drug structure formation to its lifecycle in the market. Now with tools that are smart, intelligent and automated, work is streamlined with the benefit of data driven impactful outcomes.